Catalog Number UNK-EXTREM |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032)
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Event Date 08/09/2017 |
Event Type
Injury
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Manufacturer Narrative
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Complete product detail has not been received at this time.If further information is received a follow-up medwatch will be filed as appropriate.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Patient was revised to address instability, pain and loosening at the bone to implant interface.Update 8/9/2017 reviewed der and additional information.This is an ankle revision.Product information modified accordingly to address this.The talar implant was loose at the bone to implant interface.
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Manufacturer Narrative
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No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.The investigation could not draw any conclusions regarding the reported event.Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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